Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease (COVID-19_LF)

National Research Centre, Egypt

Status and phase: Unknown; Phase 2

Conditions: COVID-19; SARS-CoV 2; Corona Virus Infection; Acute Respiratory Distress Syndrome; Middle East Respiratory Syndrome (MERS); Coronavirus Infection

Treatments: Drug: Placebo of excipient(s) will be administered; Dietary Supplement: Lactoferrin (Apolactoferrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT04412395

COVID-19_LF

Details and patient eligibility

About

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

Full description

The World Health Organization (WHO) declared the coronavirus (SARS-CoV-2, COVID-19) outbreak a Public Health Emergency of International Concern with a pandemic spread. The situation is rapidly evolving, which raises the approach of reproposing already approved drugs to meet the emerging challenge and to save time and money. Lactoferrin (Lf) is a natural glycoprotein that broadly distributed within the body fluids and found predominantly in milk. It represents a known component of the innate immune system. The antiviral activity of Lf has been reported against many viruses, including SARS-CoV-1, through blocking the viral receptors on the host cells preventing them from entry and replication. Markedly, data reveals that Lf interacts with Heparan Sulfate Proteoglycans (HSPGs) and Angiotensin Converting Enzyme 2 (ACE2) receptors that are reported as SARS-CoV-2-binding sites to enter the host cell, suggesting a potential significance of Lf as an antiviral against SARS-CoV-2. Moreover, the immunoregulatory effects of Lf can protect against the cytokine-storm and thrombotic complications that result from the COVID-19-induced over-stimulated inflammatory response and exaggerated immune reactions. In addition, Lf can decrease the free iron toxicity caused by the virus as it has a strong iron chelating ability. Lf is a safe approved food supplement that is available in the markets for enhancement of immunity and for treatment of anemia. The aim of this study is to perform a randomized, double-blind, placebo-controlled, two arms, clinical trial to assess oral enteric-coated tablet of bovine apolactoferrin (the low iron-content form of Lf) as a safe antiviral and immunoregulatory therapy in patients diagnosed with COVID-19 disease.

Enrollment: 516 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients tested positive (PCR) for SARS-CoV-2 and clinically symptomatic.
• Adult patients with age >18 years.
• Patients willing and able to sign the study informed consent form.

Exclusion criteria

• Critically severe disease patients (having Respiratory failure requiring mechanical ventilation, or signs of septic shock or multiple organ failure requiring ICU admission).
• Patients who are unconscious
• Patients who have convulsions
• Patients suffering from central cyanosis with SPO2< 90% (for asthmatic patients with SPO2<88%)
• Pregnant or lactating women
• Patients with a known history of pro-inflammatory diseases (patients with autoimmune diseases, patients receiving chemotherapy for cancer, patients with malabsorption, patients with inflammatory bowel disease, Crohn's disease or ulcerative colitis).
• History or suspected immunosuppressive or immunodeficient state including HIV infection, or chronic immunosuppressant medication (more than 14 days) within the past 3 months (inhaled and topical steroids are allowed).
• Patients with severe renal impairment (GFR <60 ml/min/1.73m2 as measured by the Cockcroft-Gault formula).
• Patient with severe hepatic impairment, biliary cirrhosis or cholestasis
• Patients who received immunoregulatory therapy within one month before the start of the study.
• Patients with Known or suspected allergy or any contraindications to Lactoferrin.
• Any condition, according to the judgment of the investigator, would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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516 participants in 2 patient groups, including a placebo group

Arm 01 (SOC + Lactoferrin 1200 mg QID)

Active Comparator group

Description:

Patients randomized to this group will receive two 600 mg Lactoferrin tablets QID plus the Standard of Care (SOC) treatment(s).

Treatment:

Dietary Supplement: Lactoferrin (Apolactoferrin)

Arm 02 (SOC + Placebo QID)

Placebo Comparator group

Description:

Patients randomized to this group will receive two placebo tablets QID plus the SOC treatment(s).

Treatment:

Drug: Placebo of excipient(s) will be administered